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Efficacy of Indacaterol 150 �...

Efficacy of Indacaterol 150 µg Versus Formoterol

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-02-29

Brief Summary

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The study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).

Patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. Patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indacaterol

Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)

Formoterol

Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)

Group Type ACTIVE_COMPARATOR

Formoterol

Intervention Type DRUG

Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)

Interventions

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Indacaterol

Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)

Intervention Type DRUG

Formoterol

Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

* Post-bronchodilator FEV1 \<80% and ≥40% of the predicted normal value
* Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
* Smoking history of at least 10 pack-years

Exclusion Criteria

* Patients who have had a COPD exacerbation in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers